{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-01",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Franklin Lakes",
      "advisory_committee_description": "Immunology",
      "address_1": "1 Becton Dr.",
      "address_2": "Mc 300",
      "statement_or_summary": "Summary",
      "product_code": "NTW",
      "openfda": {
        "device_name": "System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test",
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      "applicant": "Preanalytix GmbH",
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      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "MODIFICATION TO PAXGENE BLOOD RNA SYSTEM",
      "advisory_committee": "IM",
      "contact": "WENDY  BALLESTEROS",
      "expedited_review_flag": "",
      "k_number": "K082150",
      "state": "NJ",
      "date_received": "2008-07-30",
      "review_advisory_committee": "PA",
      "postal_code": "07417",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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